{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-30",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Baby Eczema Therapy Colloidal oatmeal WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL PANTHENOL DIMETHICONE OAT KERNEL OIL STEARETH-20 OAT BENZALKONIUM CHLORIDE CERAMIDE NP SODIUM CHLORIDE BENZYL ALCOHOL SODIUM HYDROXIDE OATMEAL OATMEAL"
      ],
      "active_ingredient": [
        "Active ingredient Colloidal oatmeal 1%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions apply as needed"
      ],
      "spl_unclassified_section": [
        "Other information store at room temperature",
        "disclaimer *This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Aveeno Baby Eczema Therapy Moisturizing Cream."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, distearyldimonium chloride, petrolatum, isopropl palmitate, cetyl alcohol, panthenol, dimethicone, Avena sativa (oat) kernal oil, steareth-20, Avena sativa (oat) kernal extract, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide"
      ],
      "adverse_reactions": [
        "Adverse Reactions DISTRIBUTED BY OLD EAST MAIN CO 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 100% Satisfaction Guaranteed! (888) 309-9030 Made in the U.S.A. with U.S. and foreign parts."
      ],
      "package_label_principal_display_panel": [
        "principal display panel *Compare to Aveeno ® Baby Eczema Therapy Moisturizing Cream Gentle Steps ® baby eczema therapy cream Colloidal Oatmeal Skin Protectant Steroid & Fragrance Free Helps to reduce itching and irritation associated with eczema NET WT 5 OZ (141 g) image description"
      ],
      "set_id": "9720e2ad-1bcf-4023-8e92-22a962df3aad",
      "id": "4c0fc0fd-720d-30d1-e063-6394a90afb72",
      "effective_time": "20260302",
      "version": "19",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Baby Eczema Therapy"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Old East Main Co."
        ],
        "product_ndc": [
          "55910-803"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "spl_id": [
          "4c0fc0fd-720d-30d1-e063-6394a90afb72"
        ],
        "spl_set_id": [
          "9720e2ad-1bcf-4023-8e92-22a962df3aad"
        ],
        "package_ndc": [
          "55910-803-28"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "8PI54V663Y"
        ]
      }
    }
  ]
}